In the midst of a massive surge in the rates of autism in the U.S. over the last two decades, the Trump administration warned Monday that pregnant women who take acetaminophen-based drugs like Tylenol may have an increased risk of having a child with autism, according to the latest data. Medical experts say that a high number of studies indicate an association between the use of Tylenol’s active ingredient acetaminophen during pregnancy and an increased risk of autism or ADHD in subsequent children.

As reported in May by the Centers for Disease Control and Prevention, about one in 31 children aged 8 are currently identified as having autism. The current rate represents an almost 400% increase since 2000, when roughly one in 150 children were identified as having the lifelong neurodevelopmental disorder which has a wide range of severity, causing difficulties with social interactions and communication and a limited range of interests and repetitive behaviors in some, with others experiencing severe disabilities in speech and behavior.

During Monday’s White House press conference, President Trump was joined by several administration officials, including Health and Human Services Secretary Robert F. Kennedy Jr. and National Institutes of Health Director Jay Bhattacharya. The health agency heads agreed that much of the current approach to autism research has failed to produce clear answers, including a narrow focus on nonmodifiable genetic factors as the cause. As Bhattacharya observed, “Genetics alone cannot explain such a sharp rise in autism prevalence over just a few decades.” He want on to announce a new $50 million autism research initiative that will use “rigorous advanced methods [including] causal inference, machine learning, organoids, and other fresh approaches to the problem.”

Food and Drug Administration Commissioner Marty Makary also spoke, pointing out that a recent Mount Sinai/Harvard study reviewed “all the existing literature, and found an overwhelming body of evidence [that] points to an association” between acetaminophen and autism. Makary also noted that the Dean of the Harvard School of Public Health recently stated that “there is a causal relationship between prenatal acetaminophen use and neurodevelopmental disorders of ADHD and autism spectrum disorder.” In addition, Makary announced that the FDA will make a medication called leucovorin more widely available for those with autism, which could help an important vitamin called folate (B9) to reach brain cells and lower autistic symptoms.

Other experts such as Dr. Robert Malone, who serves as Chief Medical and Regulatory Officer for The Unity Project, say that the Trump administration’s efforts to uncover the root causes of the current “epidemic” of conditions like autism are a welcome development.

“[We have] an epidemic of disease in children, which has all the characteristics of an environmental exposure,” he observed during “Washington Watch with Tony Perkins” Tuesday. “This is not genetics. There may be a genetic component, but genetics don’t change this rapidly. Now, the secretary and the president have emphasized the role of folate receptors and potential therapeutic intervention that may help some children suffering from autism and ADHD. But the whole press narrative that ‘This comes out of left field [and’ there’s no scientific support’ — that flies in the face of the fact that there have been data, and those data are quite strong that have existed in the peer reviewed literature now for many, many years. … So this is not a wackadoodle, from left field, Donald Trump just shooting off his mouth situation … [T]he data have been out there for a long time. They’ve been suppressed.”

Malone, who currently serves as co-chair of the CDC’s Advisory Committee on Immunization Practices, further pointed out during Wednesday’s “Washington Watch” that in 2017, Tylenol’s own Twitter account recommended against taking their products during pregnancy, stating, “We actually don’t recommend using any of our products while pregnant.”

As for the current debate raging over childhood immunizations, Malone, who spent most of his career as a vaccinologist, contended that adequate testing on the safety of vaccines have yet to be fully carried out.

“[V]accines historically, for children in particular, have been licensed without adequate negative controls,” he argued. “So we really don’t know what the spectrum of adverse events are, because we built a pyramid of logic that it’s somehow unethical to not administer a vaccine to a child as a control group so that we can assess whether or not those products are causing certain types of adverse events.”

Malone continued, “We also have never done the investigations on the interactions of these products, essentially drug interactions in any other part of pharmacology and regulatory affairs. Drug interactions are central to decisions about licensure and recommendations. But for some reason [with] vaccines, there’s a prohibition on asking those questions. For some reason, vaccines are treated as if they are something different, not really a drug, something that’s sacrosanct, that is almost a religion in and of itself. … But the truth is that these are just drugs and they have adverse events. They have made huge impacts on certain infectious diseases. … But that doesn’t mean that they don’t have side effects.”

Malone concluded by urging parents to work with their doctors and fully inform themselves before taking any medications.

“My recommendation is to be very cautious,” he underscored. “… [T]he pragmatic thing is to have an active discussion with your pediatrician and [to] take responsibility for your child’s health [by] making an informed decision. Don’t allow anybody to bully you or shame you into accepting something that you don’t feel comfortable with. That’s the fundamentals of informed consent.”